(39 days)
Electrosurgical accessory. Monopolar electrosurgical coagulator for controlling bleeding by use of high-frequency electrical current and a suction tube for removal of fluids and debris from the surgical site.
Monopolar Suction Coagulator
This document is a 510(k) clearance letter from the FDA for a Monopolar Suction Coagulator. It does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria related to AI or algorithm performance.
The letter is a regulatory document confirming that the device is substantially equivalent to legally marketed predicate devices and can be marketed. It focuses on regulatory compliance, classification, and general controls, not on detailed performance metrics from a specific study.
Therefore, I cannot extract the requested information from the provided text.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 4 1998
New Deantronics Taiwan, Ltd. c/o L.W. Ward and Associates, Inc. Mr. Lewis Ward 4655 Kirkwood Court Boulder, Colorado 80301
Re: K982746 Trade Name: Monopolar Suction Coagulator Regulatory Class: II Product Code: GEI Dated: July 31, 1998 Received: August 6, 1998
Dear Mr. Ward:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Ward
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K982746 Initial 510(k)
Device Name: New Deantronics, Inc. Model SB 110-1 Monopolar Suction Coagulator.
Indications for Use:
Electrosurgical accessory. Monopolar electrosurgical coagulator for controlling bleeding by use of high-frequency electrical current and a suction tube for removal of fluids and debris from the surgical site.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of DCRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR Over-the-Counter Use
Acosta
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K982746
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§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.